Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201707002379181 Date of Approval: 27/06/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Erector Spinae Plane Block for flail chest
Official scientific title Ultrasound guided Erector Spinae Plane Block versus thoracic epidural analgesia in traumatic flail chest
Brief summary describing the background and objectives of the trial Rib fractures occur in up to 39% of patients with blunt chest trauma [1] and can result in a mechanically unstable chest wall or ¿flail chest¿ which is defined as three or more consecutive rib fractures, in two or more locations, creating a flail segment [2]. Flail chest can impair ventilation with subsequent prolonged mechanical ventilation, barotrauma and increased the risk for pneumonia, sepsis, long ICU stay, and death [3]-[5]. Pain is recognized as a contributing factor for most of this associated morbidity,6¿9 and analgesia is a core intervention in managing these patients. 7,10 Multiple analgesic modalities have been used in patients with rib fractures,11 such as oral analgesics,12 intravenous opioids,13 patient-controlled opioid analgesia,14 interpleural blocks,13 intercostal blocks,15 paravertebral blocks,16 and epidural analgesia.17,18 The ultrasound-guided erector spinae plane (ESP) block is a recently described regional anesthetic technique for providing thoracic analgesia when performed at the level of the T5 transverse process. Local anesthetic injected into the fascial plane deep to the erector spinae muscle spreads in a craniocaudal fashion over several levels. Local anesthetic also penetrates anteriorly through the intertransverse connective tissue and enters the thoracic paravertebral space where it can potentially block not only the ventral and dorsal rami of spinal nerves but also the rami communicantes that transmit sympathetic fibers 19,20. The aim of this study is to compare the analgesic effects of ultrasound-guided erector spinae plane (ESP) block versus thoracic epidural in patients with traumatic flail chest.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,analgesia,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/05/2017
Actual trial start date 01/07/2017
Anticipated date of last follow up 01/11/2017
Actual Last follow-up date 10/01/2021
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
31508/04/17 Tanta University, Faculty of Medicine,Research Ethics Committee, Quality Assurance Unit
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised permuted block randomisation Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Thoracic epidural group E a loading dose of 6 ml of 0.25% bupivacaine and 2 µg/ml fentanyl, followed by continuous infusion of 6 ml/hour bupivacaine 0.125% and 2µg/ml fentany 96 hours Thoracic epidural 30 Active-Treatment of Control Group
Experimental Group ultrasound guided Erector Spinae Plane Block group ESPB 20 mL of 0.25% bupivacaine and 2µg/ml fentanyl followed by continuous infusion of 6 ml/hour bupivacaine 0.125% and 2µg/ml fentanyl 96 hours Erector Spinae Plane Block 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
patients aged 18 ¿ 60 years, of either gender, ASA I-II, isolated chest trauma patient refusal, body mass index more than 30 kg/m2, the need for mechanical ventilation on admission, psychiatric illness contraindications for performing epidural insertion as Coagulopathy, Vertebral column deformities, local infection trauma survey include abdominal or head injury. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 60 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 01/04/2017 Tanta University, Faculty of Medicine, Research Ethics Committee, Quality Assurance Unit
Ethics Committee Address
Street address City Postal code Country
10 Algeish street Tanta 31951 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome VAS score during the first 96 postoperative hours recorded immediately after the block, 1 hr, 2hr, 4hr, 6 hr, 8hr, 12hr, 24hr, 48hr, 36h, 60h, 72h, 84h and 96h
Secondary Outcome total postoperative pethidine consumption 96 hrs postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University, Faculty of Medicine 10 Algeish street Tanta Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Tanta University, Faculty of Medicine 10 Algeish street Tanta 31951 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Department of anesthesia and surgical ICU 10 Algeish street Tanta 31951 Egypt Hospital
Primary Sponsor Tanta University, Faculty of Medicine 10 Algeish street Tanta 31951 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Shaimaa Farouk 1 Moheb street Almahalla Alkobra 31951 Egypt
Mohamed Mohye Eldin 55 Stad street Tanta 31951 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Shaimaa Farouk Shaimaafarouk7777@yahoo.com 01270440771 1 Moheb street
City Postal code Country Position/Affiliation
Almahalla Alkobra 31951 Egypt Lecturer ofanesthesia and ICU
Role Name Email Phone Street address
Public Enquiries Shaimaa Farouk Shaimaafarouk7777@yahoo.com 01270440771 1 Moheb street
City Postal code Country Position/Affiliation
Almahalla Alkobra 31951 Egypt Lecturer ofanesthesia and ICU
Role Name Email Phone Street address
Scientific Enquiries Mohamed Mohye Eldin Mohd_yazed75@yahoo.com 01120014472 55 Stad street
City Postal code Country Position/Affiliation
Tanta 31951 Egypt Lecturer ofanesthesia and ICU
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information